Sterile Drug Manufacturing Facilities
Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation

Upcoming Dates and Locations

Date				Location	Country	Instructor(s)
19-20 May 2008				Brussels Training Series Brussels	Belgium	Robert Walker

Description

This course references ISPE’s Sterile Manufacturing Facilities Baseline® Guide and the FDA’s newly published Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice. Both of these documents help provide an understanding of the key requirements and GMPs for sterile manufacturing facilities. The Baseline® Guide provides valuable information on design, construction, and commissioning/qualification while the FDA’s new Guidance helps professionals understand the regulatory context and expectations for sterile drug manufacturing.

Using the referenced documents, this course will cover regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, basic utility systems, European HVAC considerations, basic commissioning and qualification issues, and a brief introduction to barrier isolation technology. (Note: parts of Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice that do not focus on facilities and equipment will not be discussed in detail.)

In addition, the course will include an exercise in the layout of an aseptic filling facility. In many cases, when a new facility is required within an existing or new building, the designer will begin by sketching a floor plan. This exercise will demonstrate how to use process flow diagrams and an accommodation schedule to thoroughly define facility requirements before advancing to the floor plan layout stage.

Participants will receive a complimentary copy of the Sterile Manufacturing Facilities Baseline® Guide.

Take Back Your Job

• Identify sources of contamination in aseptic operations
• Explain methods for contamination control
• Describe the major requirements for design, renovation, and operation of a sterile manufacturing facility
• Discuss the fundamentals of aseptic clean room design
• Understand the importance of monitoring critical parameters: temperature, humidity, air velocity, differential pressure, airflow patterns, non-viable particle counts, and microbial counts
• Design a systematic process for aseptic facility layout
• Apply ISO 14644, Clean Rooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness to Aseptic Processing Clean Rooms
• Discuss the difference between U.S. and European clean room HVAC standards
• Distinguish between the 2004 and 1987 versions of the FDA’s Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice as applied to the design, operation, maintenance, and modification of facilities

Attendance Suggested For

• Engineers, validation scientists, quality assurance specialists, and manufacturing managers
• Professionals who want a fundamental understanding of sterile manufacturing facilities and their design, renovation, and operation
• Engineering firm professionals and other consultants who work with the pharmaceutical industry

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.